VANCOUVER, Nov. 5, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) today announced its unaudited operating results for the three and nine-month periods ended September 30, 2012. Allon also reported that it is on track to advance toward commercialization of its lead neuroprotective drug candidate davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease.
Gordon McCauley, President and CEO of Allon Therapeutics, said the quarter's progress has kept the company on track to meet its schedule of completing patient treatment as well as analysis and release of top-line data before the end of 2012 for the multinational phase 2/3 pivotal clinical trial that is evaluating davunetide in more than 300 PSP patients.
"Our shareholders stand with thousands of patients, caregivers, families, and health professionals in search of a treatment for this debilitating and fatal disease," McCauley said.
Allon estimates the market potential for the first approved treatment for PSP will exceed $700 million in the U.S. and Europe. PSP affects approximately 25,000 people in the United States and 40,000 people in the European Union. Patients are typically diagnosed when they are between 45 and 65 years of age.
Allon's pivotal trial is proceeding under a Special Protocol Assessment with the U.S. Food and Drug Administration. This multi-national study is being conducted in the United States, Canada, the United Kingdom, France, Germany and Australia. The trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.
PSP is considered a tauopathy, involving the tau protein in brain cells. Allon has previously demonstrated, in both preclinical and clinical studies, that davunetide has an impact on the tau pathology. The current evaluation of davunetide in a pivotal clinical trial as a potential treatment for PSP makes it the most advanced tau therapy in the world.
The Company believes that success in treating PSP with davunetide would define the opportunity to evaluate davunetide in other tau-related diseases, such as Alzheimer's, subtypes of frontotemporal dementia, as well as other neurodegenerative diseases such as schizophrenia and Parkinson's.
Results of operations
Allon reported a net loss of $1,847,863 ($0.01 per share) for the three months ended September 30, 2012, compared to a net loss of $2,983,887 ($0.04 per share) for the three months ended September 30, 2011, representing a decrease in net loss of $1,136,024. For the nine months ended September 30, 2012, the Company reported a net loss of $7,869,780 ($0.07 per share), compared to a net loss of $8,877,797 ($0.11 per share) for the nine months ended September 30, 2011. This decrease in net loss is explained in the following description of significant variances from the comparable periods in 2011.
For the three and nine months ended September 30, 2012, research and development expenses were $1,292,607 and $5,688,077 compared to $2,235,554 and $6,448,571 for the three and nine months ended September 30, 2011. Research and development expenses were lower compared to the same period in 2011 due to less clinical trial activities related to PSP as the clinical trial nears completion. Research and development expenses for the three and nine months ended September 30, 2012 also included amortization and depreciation expenses of $127,136 and $381,961 (2011 - $127,401 and $382,753) and share-based compensation of $17,013 and $55,597 (2011 - $15,434 and $39,620).
For the three and nine months ended September 30, 2012, general and administrative expenses were $568,986 and $2,024,416 compared to $665,722 and $2,204,706 for the three and nine months ended September 30, 2011. General and administrative expenses for the three and nine months ended September 30, 2012 were lower compared to the same periods in 2011 primarily due to lower corporate development activities and lower general overhead expenses partly offset by higher compensation expenses. Included in general and administrative expenses for the three and nine months ended September 30, 2012 were share-based compensation of $77,566 and $231,068 (2011 - $44,440 and $139,642) and amortization and depreciation expenses of $1004 and $6,007 (2011 - $3,169 and $10,249).
The Company's other income and expenses are comprised of loss on debt repayment, interest income/expense and foreign exchange gains/losses.
Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies. Allon's lead drug davunetide is proceeding in a pivotal clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The trial is fully enrolled and on track to complete the study, analyse the data and release top-line results before the end of 2012. This pivotal trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and in positive biomarker data.
The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC".
Forward Looking Statements
Statements contained herein, other than those which are strictly statements of historical fact may include forward-looking information. Such statements will typically contain words such as "believes", "may", "plans", "will", "estimate", "continue", "anticipates", "intends", "expects", and similar expressions. While forward-looking statements represent management's outlook based on assumptions that management believes are reasonable, forward-looking statements by their nature are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by them. Such factors include, among others, the inherent uncertainty involved in scientific research and drug development, Allon's early stage of development, lack of product revenues, its additional capital requirements, the risks associated with successful completion of clinical trials and the long lead-times and high costs associated with obtaining regulatory approval to market any product which Allon may eventually develop. Other risk factors include the limited protections afforded by intellectual property rights, rapid technology and product obsolescence in a highly competitive environment and Allon's dependence on collaborative partners and contract research organizations. These factors can be reviewed in Allon's public filings at www.sedar.com and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements. Similarly, nothing in this press release is meant to promote a pharmaceutical product or make a regulated claim of efficacy.
SOURCE Allon Therapeutics Inc.